Breathing assistance device with linear actuated gas regulating valve

ABSTRACT

A breathing assistance device includes a gas regulating valve ( 1300 ). The gas regulating valve is operated by a linear actuator ( 1330 ). The linear actuator may include a movable member that moves an obstruction member between an open position and a closed position. The linear actuator is isolated from a gas flow path through the valve.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 13/377,244, filed Dec. 9, 2011, now allowed, which is the U.S.national phase of International Application No. PCT/AU2010/000708, filedJun. 9, 2010, which designated the U.S. and claims the benefits of U.S.Provisional Patent Application Ser. No. 61/185,250, filed Jun. 9, 2009,the entire contents of each of which are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates to a breathing assistance device, and morespecifically, to a linear actuator that is used in a gas regulatingvalve of a breathing assistance device.

BACKGROUND OF THE INVENTION

A variety of breathing assistance devices, which we will also generallyrefer to as “respirators” in this text, are available today. Theserespirators are equipped with a source of respiratory pressurized gas.They are generally referred to as “autonomous” because an externalpressurized gas feeding is not required to operate them. These devicesprovide the patient, at each inspiration, with a respiratory gas(typically ambient air to which a complementary gas such as oxygen canbe added).

Different types of respirators are known. These different types ofrespirators can be classified according to their size, because the sizeof these devices is an important parameter. It is generally desirable tominimize the size of the respirator in order to facilitate the operationof the respirator in multiple different locations, for instance, at homeas well as in the hospital. In addition, smaller sized respirators tendto increase the mobility of the patient.

Non-Transportable Respirators

A first type of respirator is generally referred to as anon-transportable respirator. A non-transportable respirator isschematically illustrated in FIGS. 1a to 1d . Such devices are generallyequipped with a respiratory gas source 51 having a very large sizeand/or weight. This gas source can be internal to the device, orexternal to the device. The source of gas 51 is commonly coupled to thepatient P through two ducts, however, a single duct may be used. Aninspiration duct 11 is dedicated to the inspiration phase, and itcarries pressurized gas from the source of gas to the patient P duringinspiration. An expiration duct 12 is dedicated to the expiration phase,and it carries expiratory gases, such as carbon dioxide, which areexhaled by the patient during the expiration phase.

These non-transportable respirators are further provided with aninspiratory valve 13 and an expiratory valve 14. These two valves arelocated close to the gas source 51 on the inspiration duct 11 and on theexpiration duct 12, respectively. The inspiratory valve 13 controls theflux of the pressurized gas transmitted to the patient during therespiratory phases. The expiratory valve 14 allows the expiratory gasesof the patient to pass out of the expiratory duct 12, and into thesurrounding atmosphere. The expiratory valve can be controlled based ona Positive End Expiratory Pressure (PEEP) control scheme.

Most of the operating modes of the respirators require monitoring of theexpiratory gas flow and/or expiratory pressure. Therefore one or moresensors 19 for sensing the gas flow and/or pressure are located in theexpiration duct 12. Each sensor usually needs to be connected to thecentral unit 10 of the respirator by at least three wires, in order tobe supplied with power and to convey data. Therefore the sensors 19 aregenerally located near the gas source S1 in order to avoid furtherincreasing the complexity of the already quite complex and large doubletransmission circuit by the addition of sensors and wires. Both theinspiratory and expiratory valves require specific and often complexcontrol systems, usually in the form of a processor or controller 15,which is coupled to or otherwise in communication with the valves andthe sensor 19.

Non-transportable respirators are generally provided with relativelylong ducts, typically of about 150 to 180 cm. This configuration resultsin a high breathing resistance, which increases the work of breathingfor the patient. Indeed, if the expiratory valve 14 is located at theend of the expiration duct 12 near the gas source S1 (the “distal end”),and the expiration duct 12 is relatively long, the patient P will needto “push” his expiration through the expiration duct 12 until theexpired air reaches the expiration valve 14 wherein it is vented to theatmosphere.

When connected to a non-transportable respirator, the patient P willalways be able to expire through the expiration duct 12, even if the gassource S1 is disabled, as shown in FIG. 1d . During expiration, thepositive pressure of the expiratory gases will cause a safety backflowvalve 16 on the inspiration duct 11 to close, and the expiration valve14 on the expiration duct 12 to open. Thus, the patient will be able toexpel expiration gases.

Also, if the gas source S1 is disabled, the patient will be able to drawin atmospheric gases through the inspiration duct 11. As shown in FIG.1c , during the inspiration phase, the patient will be able to draw inatmospheric gas through the safety back flow valve 16 on the inspirationduct, and the expiration valve 14 on the expiration duct 12 will beclosed. The safety back flow stop valve 16 is not located on theexpiration duct 12 because it would be dangerous for the patient P toinspire through the expiratory duct 12, which usually contains expiredcarbon dioxide.

Transportable Respirators

A second type of respirator can be referred to as transportablerespirators. A transportable respirator is schematically illustrated inFIGS. 2a to 2d . This transportable respirator is provided with acentral unit 20 comprising an internal respiratory gas source S2. Thegas source S2 may be a small turbine or blower, having optimizedcharacteristics in order to limit the volume occupied by the device.

These transportable respirators typically use a single gas transmissionduct 21 between the source S2 and the patient P, in contrast withdevices having two ducts (an inspiration duct and an expiration duct).The respirators use an expiratory valve 22 located on the single duct21, near the patient P (i.e. at the proximal end of the duct). Incontrast to the above-described non-transportable respirators, theproximal location of the expiratory valve 22 eliminates the breathingresistance phenomenon during the expiratory phase which is caused by thelength of the duct in a non-transportable respirator between the patientand the expiratory valve.

In typical transportable respirators, as illustrated in FIGS. 2a to 2d ,the expiratory valve 22 is a pneumatic valve that is operated by apressurized air feeding conduit 23, coupled between the respiratory gassource S2 (or to another source of pressure such as an independentmicro-blower) and an obstructing cuff 24 of the expiratory valve 22. Thepressure from the gas source S2 inflates the obstructing cuff 24 duringthe inspiration phase to ensure that the gas traveling along thetransmission duct 21 is delivered to the patient P.

The control of the expiratory valve thus requires a second conduit 23,which obviously limits the miniaturization of the respirator,particularly the breathing circuit. During the expiration phase, theexpiratory valve 24 is either opened or partially closed in order toestablish a positive end expiratory pressure (PEEP) in the gastransmission duct to balance the residual overpressure in the patientlungs. In order to establish such a PEEP, it is necessary to control,very precisely, the pneumatic inflating pressure of the cuff 24 of theexpiratory valve 22. This increases the complexity of the controller 25of the respirator.

In some respiratory modes, the expiratory valve 22 has to be operated asmuch as possible in real time, which is quite difficult in suchexpiratory valves because of the pneumatic inertias which are associatedwith them. Moreover the configuration of such a known respirator imposesa limitation of the value of the PEEP at around 20 cmH₂O, while somerespiratory modes would need a higher value of the PEEP (e.g. 40 cmH₂Oor even more).

For the same reason as for non-transportable respirators, the expiratorygas flow and/or expiratory pressure may have to be controlled, and thusgas flow and/or pressure sensors 29 will typically be provided near theexpiratory valve 22. Here again, this requires providing wires along thegas transmission duct 21 between the central unit 20 and the patient P.Usually three wires (two for power supply and one for data transmission)are provided for each pressure sensor and each gas flow sensor. Sinceexpiratory gas flow and pressure generally have to be measured, aconnection cable 26 of at least five wires is thus required between thecentral unit 20 and the expiratory valve 22 at the proximal end of thedevice.

In order for the patient to safely use such a transportable respirator,the device must allow the patient to breathe in any situation, includingif the pressurized gas source is disabled. With a respirator having asingle gas transmission duct 21 and a separate conduit 23 for pneumaticcontrol of the expiratory valve 22, the patient P can always expirethrough the pneumatic expiratory valve 22, even if the pneumatic feedingof the expiratory valve 22 is disabled, as shown in FIG. 2d . Indeed, ifthe pneumatic feeding of the expiratory valve is disabled, which wouldbe the case when the gas source is disabled, the cuff 24 of theexpiratory valve 22 will not be inflated, and the patient P will be ableto expire expiratory gases E_(P) through the expiratory valve 22. Insuch case, it will be impossible for the patient P to inspire throughthis pneumatic expiratory valve 22, since the cuff 24 will obstruct thepassage. However, the patent P will be able to inspire via the safetyback flow stop valve 27 located on the inspiration conduit 21, as shownin FIG. 2c . As shown in FIG. 2a , this safety valve 27 will normally beclosed under the effect of the pressure feeding a coming from the gassource S2. But if the gas source S2 is disabled, the pressure of thepatient inspiration Ip will open the safety valve 27, allowing thepatient P to inspire air from outside, as illustrated in FIG. 2 c.

In order to allow a safe inspiration through the safety valve 27 and thewhole length of the duct 21, the diameter of the duct must be relativelylarge. There are generally pressure loss standard requirements tofulfill for addressing this issue of safety. For example, the Frenchstandards state that the maximum pressure loss between the source andthe patient must not exceed 6 hPa for 1 litre/second for an adult and 6hPa for 0.5 litre/second for a child. In order to fulfill theserequirements, the transmission duct of typical devices as illustrated inFIGS. 2a to 2d must have a minimum diameter of 22 mm for an adult, and aminimum diameter of 15 mm for a child. The requirement for such largediameter ducts is an obstacle to miniaturization of the device,particularly the breathing circuit.

For the same reasons as for the transportable respirators, the diametersof the ducts on the non-transportable respirators illustrated in FIGS.1a-1d must be relatively large to fulfill the pressure lossrequirements. That is, the ducts must have a diameter of at least 15 mmfor children and 22 mm for adults in order to allow a safe inspirationthrough the safety valve 16. And here again, such large duct diametersis an obstacle to miniaturization.

The pathologies and diseases to be treated by the above-describedrespirators are varied, and the breathing assistance devices cantherefore be of different types. The respirators can bepressure-controlled or volumetric-controlled, and they can be operatedaccording to different operating modes. Each operating mode is definedby particular setting and checking variables, but also by a particulartype of material.

Some respirators, which can be referred to as hybrid respirators, areable to work according to several operating modes. However theirmaterial configuration, in particular the accessories (such as the typeof ducts between the gas source and the patient, the presence of anexpiratory valve, the use of a mask with apertures, etc.), must beadapted to the chosen operating mode.

It would be desirable to allow a single device to operate according to alarge variety of modes, without requiring that the device be modifiedfor each mode, such as by adapting its ducts, accessories, etc.

SUMMARY OF THE INVENTION

One aspect of the invention relates to a linear actuator for a gasregulating valve that includes a housing, a yoke mounted inside thehousing, and a bobbin that is movably mounted inside the yoke and thathas first and second arms that extend from a first end of the bobbin,wherein a wire coil is wrapped around the bobbin. The linear actuatoralso includes a flexible circuit assembly having a central portion thatis attached to the yoke and first and second extensions that extend fromthe central portion and that are attached to the first and second armsof the bobbin, respectively. First and second electrical contacts areformed on the central portion, the first and second electrical contactsbeing coupled, respectively, to first and second ends of the wire coil.The linear actuator also includes a magnet that is attached to the yoke.Preferably the linear actuator, the housing, yoke, bobbin and magnethave a generally cylindrical shape.

Another aspect of the invention relates to a gas regulating valve thatincludes a linear actuator having a central passageway extendingtherethrough, a first housing portion configured to be attached to a gasdelivery tube, and a second housing portion configured to be attached toa patient interface. One of the first and second housing portionsextends at least partially through the central passageway of the linearactuator. The linear actuator can actuate a membrane assembly that iscoupled between the first and second housing portions such that a gaspassing through the first and second housing portions and through themembrane assembly is isolated from the linear actuator.

Another aspect of the invention relates to a method of manufacturing agas regulating valve that includes the steps of inserting a first end ofa first housing portion through a linear actuator to form a firstsection of a central passageway, inserting a membrane assembly into thefirst end of the first housing portion and coupling a first end of themembrane assembly to the first housing portion to form a second sectionof the central passageway, connecting the first housing portion and asecond housing portion by a latch system on their external surface suchthat the second housing portion provides the third section of thecentral passageway and the gas regulating valve is encapsulated in oneunit. The full actuating of the linear actuator couples a second end ofthe membrane assembly to the second housing portion such that a throughcentral gas passageway is formed by the first housing portion, themembrane assembly and the second housing portion, and the gas passagewaybeing isolated from the linear actuator.

Another aspect of the invention relates to a method of manufacturing alinear actuator that includes the steps of inserting a hollow bobbinhaving a wire coil wound thereon inside a hollow yoke, attaching acentral portion of a flexible circuit assembly to the yoke, the flexiblecircuit assembly having first and second arc-shaped extensionsprotruding from the central portion, and coupling first and second endsof the wire coil to the first and second arc-shaped extensions of theflexible circuit assembly. The method also includes the steps ofinserting a hollow magnet inside the cylindrical bobbin, and attachingthe magnet to the yoke.

Another aspect of the invention relates to a method of treating apatient with a breathing assistance device which includes a gas supply,a patient interface, a gas supply line coupling the gas supply and thepatient interface, and a gas regulating valve that controls a flow ofthe gas from the gas supply to the patient interface, wherein the gasregulating valve includes a linear actuator that is sealed off from thepatient airway. The method includes the steps of sensing a gas pressurein one of the supply line and the patient interface, and sending acontrol signal which is based on the sensed gas pressure to the linearactuator of the gas regulating valve to cause linear movement of a coilof the linear actuator, wherein the linear movement of the coil causesan obstruction member of the gas regulating valve to move.

Another aspect of the invention involves a method of treating a patientwith a breathing assistance device which includes a patient interfacewith a linear actuator that controls a size of an exhalation vent of thepatient interface, wherein the linear actuator is sealed off from thepatient airway, a gas supply and a supply line coupling the gas supplyand the patient interface. The method includes sensing a gas pressure inat least one of the gas supply line and the patient interface, andsending a control signal which is based on the sensed gas pressure tothe linear actuator to cause linear movement of a coil of the linearactuator, wherein the linear movement of the coil causes an obstructionmember of the exhalation vent to move.

Another aspect of the invention involves a breathing assistance devicethat includes a gas supply, a patient interface, a gas supply linecoupling the gas supply and the patient interface, and a gas regulatingvalve coupled between the gas supply and the gas supply line. The gasregulating valve controls a flow of the gas from the gas supply to thepatient interface, and the gas regulating valve includes a linearactuator that is sealed off from the patient airway.

Another aspect of the invention involves a breathing assistance devicethat includes a gas supply, a gas supply line coupled to the gas supply,a patient interface, a pressure sensor that senses a pressure within thepatient interface, and a gas regulating valve coupled between the gassupply line and the patient interface. The gas regulating valve includesa movable obstruction member that moves between a closed position atwhich the gas regulating valve couples the gas supply line to thepatient interface and an open position at which the gas regulating valvecouples the patient interface to the atmosphere. the breathingassistance device also includes a controller that is coupled to thepressure sensor and the gas regulating valve. The controller sends acontrol signal to the gas regulating valve that controls a degree towhich the obstruction member moves from the open position toward theclosed position. The controller calculates an expiratory flow of thepatient when the patient is exhaling based upon a pressure within thepatient interface, as sensed by the pressure sensor, and a value of thecontrol signal sent to the gas regulating valve.

Another aspect of the invention involves a method of calculating apatient's expiratory flow when the patient is using a breathingassistance device that includes a patient interface that is coupled to agas regulating valve, and wherein a control signal is applied to the gasregulating valve to control a flow through gas regulating valve. Themethod includes determining a pressure difference between a pressurewithin the patient interface and atmospheric pressure while the patientis expiring, determining a value of the control signal applied to thegas regulating valve while the patient is expiring, and calculating thepatient's expiratory flow based on the determined pressure differenceand the determined value of the control signal.

Further aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIGS. 1a-1d illustrate a background art non-transportable respirator;

FIGS. 2a-2d illustrate a background art transportable respirator;

FIG. 3 is a schematic representation of a breathing assistance device;

FIGS. 4a-4c illustrate operating modes of gas regulating valve;

FIGS. 5a and 5b illustrate operating modes of another type of gasregulating valve;

FIGS. 6a and 6b are perspective views of a linear actuator that can beused in the gas regulating valves described above;

FIG. 7 is an exploded view of portions of the linear actuator shown inFIGS. 6a and 6 b;

FIG. 8 is a perspective view of the coil assembly of the linearactuator;

FIGS. 9a-9e illustrate steps of assembling the linear actuator shown inFIGS. 6a and 6 b;

FIG. 10 is a perspective view of the housing of the linear actuator ofFIGS. 6a and 6 b;

FIG. 11 illustrates the final step in assembling the linear actuatorshown in FIGS. 6a and 6b ; and

FIG. 12 is an exploded perspective view of a valve assembly thatincorporates a linear actuator;

FIG. 13 is an exploded perspective view of an obstructing mechanism anda flow restrictor of the valve assembly shown in FIG. 12;

FIG. 14 is a cross-sectional view of the valve assembly shown in FIG.12;

FIGS. 15a and 15b illustrate the valve assembly shown in FIG. 12 in theopen and closed positions;

FIG. 16 illustrates a variable vented respiratory mask including alinear actuator;

FIG. 17 is a schematic representation of a breathing assistance devicewhich makes use of a gas regulating valve adjacent a gas source;

FIG. 18 is a schematic representation of a breathing assistance devicewhich makes use of two gas regulating valves located at opposite ends ofa gas delivery tube;

FIG. 19 is a schematic diagram of elements of a breathing assistancesystem that includes a linear actuated gas regulating valve; and

FIG. 20 is a schematic diagram of elements of another embodiment of abreathing assistance system which makes use of a linear actuated gasregulating valve.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including,” and thus not limitedto its “closed” sense, that is the sense of “consisting only of ” Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. It is also acknowledged that the blowersdescribed herein may be designed to pump fluids other than air.

General Structure of Respirator and Breathing Assistance Device

We shall first describe the general structure of a device which can beused as a respirator, or a breathing assistance device, as illustratedin FIG. 3. Some embodiments of the device could also be used as acontinuous positive airway pressure (C-PAP) device for treating sleepapnea and other similar conditions. For instance, the device could bepart of a ventilator operating in a C-PAP mode.

Also, because the gas regulating valve is highly controllable, thedevice can also be used as a Bi-level positive airway pressure (Bi-PAP)device which delivers air or gas at a higher pressure during inhalationthan during exhalation. The device could also be operated in a modewhere the gas pressure is under active variable control.

This device comprises a central unit 30, which itself includes aninternal gas source S for supplying a patient P with respiratorypressurized gas. The gas source S is typically a small blower. In someinstances, the gas source could also include an oxygen blender capableof introducing selected amounts of oxygen into the gas being deliveredto the patient. Details of an oxygen blender system can be seen inInternational Application No. PCT/IB2005/002326 (Publication No. WO2006/136878), which was filed on Jun. 23, 2005, the contents of whichare hereby incorporated by reference. The breathing assistance devicefurther comprises a gas transmission circuit between the central unit 30and the patient P, so as to allow the patient P to inspire and expire.

A gas regulating valve 32 is interposed in said gas transmission circuitat a proximal location. The term “proximal location” means that the gasregulating valve 32 is located near (e.g., typically a few centimeters)the end of the gas transmission circuit coupled to the patient P. Asshall be described further in this text, the regulating valve can bemade according to many different embodiments, some examples of which aredescribed below. Additional embodiments of such a gas regulating valvecan be seen in International Application No. PCT/EP2006/061989(Publication No. WO 2006/117379), filed on May 2, 2006, the contents ofwhich are hereby incorporated by reference.

The gas source S will preferably be capable of operating according toseveral respiratory modes. This gas source is connected to an air inlet33 a for collecting ambient air to be provided to the patient P. Anadditional inlet 33 b may also be provided for a secondary respiratorygas such as oxygen, in order to enrich the ambient air. The gas source Sis powered through a power supply 37. This power supply 37 may be aninternal battery or an external power supply.

The gas transmission circuit may be composed of one or more gastransmission ducts. As shown in FIG. 3, in one embodiment, the breathingassistance device includes a gas transmission circuit consisting of asingle gas transmission duct 31. This gas transmission duct 31 comprisesa distal end 31 d coupled to the source S and a proximal end 31 pcoupled to the patient P. The proximal end 31 p of the transmission duct31 is connected to the patient P through a connecting device, e.g., apatient interface 36. This patient interface 36 may be a device adaptedfor tracheotomy or a mask, such as a nasal mask, a full face mask, orthe patient interface could be adapted to connect to nasal inserts,nasal plugs and other such devices. In an alternate embodiment, thebreathing assistance device may include two separate gas transmissionducts, one for inspiration and one for exhalation.

The breathing assistance device further includes a processor orcontroller 35 for controlling the gas regulating valve 32 via aconnection link 39, which is used for data transmission and powersupply. This connection link 39 can be a connection cable 39. Thecontroller 35 is coupled to one or more measurement devices, i.e.sensors 34. The sensors would typically include a gas flow sensor and apressure sensor, which are coupled to the controller 35 via theconnection cable 39. Part or all of these sensors can be locatedproximally, that is located near the gas regulating valve 32. It is alsopossible that part or all of these sensors are located on another partof the gas transmission duct 31, such as near its distal end 31 d. Thecontroller 35 further includes a data processing device for processingof the signals coming from the different sensors, which could includehardware, software and possibly firmware.

In some embodiments, the data processors of the controller 35 can belocated at a distal position, that is on the gas source S. In otherembodiments, the data processors may be located at a proximal position,that is near the patient P. Indeed, the more sensors there will be nearthe gas regulating valve 32, the more wires there will have to be in theconnection cable 39 along the gas transmission duct 31. To help reducethe number of wires, it may be advantageous to provide a proximal dataprocessor 38 adjacent the gas regulating valve 32 so that multipledifferent signals from the sensors can be processed at the proximallocation, and then transmitted to distal data processor of thecontroller 35 through a single data transmission wire. In this instance,it may only be necessary to have three wires, i.e. one data transmissionwire and two power supply wires.

The gas transmission duct 31 may be of different diameters. Inparticular, this gas transmission duct 31 may have a smaller diameterthan the ducts used in the known breathing assistance devices such asthose represented in FIGS. 1a-1d and 2a -2 d. As will be explained inmore detail below, the characteristics of the gas regulating valve 32,which is interposed in the gas transmission duct 31, allows this type ofbreathing assistance device to fulfill the pressure loss and safetystandards without needing a relatively large diameter duct. It istherefore possible for the gas transmission duct 31 to have an externaldiameter smaller than 22 mm for adults (19 mm internal diameter) andsmaller than 15 mm for children. For example the gas transmission ductfor adults may have an internal diameter of between 10 mm and 18 mm, orbetween 12 mm and 17 mm, such as 15 mm.

The gas regulating valve 32 is controlled in a manner independent of thepneumatic pressure supplied to the valve, so that no separate airfeeding conduit is required to operate the valve. For example the gasregulating valve 32 may be electrically controlled. This also allows thegas regulating valve to respond faster in real time as there is nopneumatic inertia to delay the response. This leads thus to a morecompact device. Miniaturization of the breathing assistance device isfurther increased when using data processors 38 located on the gasregulating valve, i.e. proximally. Despite these differences from therelated art breathing assistance devices described above, the breathingassistance device remains also highly safe and reliable.

Operational Methods of the Gas Regulating Valve

The gas valve described above is configured so that even if there is abreakdown of the gas source or the controller, the patient will be ableto breathe. This will be explained with references to FIGS. 4a-c, 5a and5 b, which together illustrate the basic operational concepts of theabove-described valve.

FIGS. 4a-c illustrate a first type of valve where a cylindricalobstruction element either blocks or opens apertures on an exterior ofthe cylindrical valve body. In this embodiment, the gas traveling fromthe gas source to the patient would travel down the center of thecylindrical obstruction element. FIGS. 5a and 5b illustrate a differentvalve construction where the blocking element is located off to one sideof the gas main passageway. Although the valve is illustrated as acylinder having a circular cross-sectional shape, it is noted that thevalve may have other cross-sectional shapes such as square, rectangular,or any other geometric shape.

The normal operation of the device corresponds to the case when both thegas source S and the controller 35 are operating normally. As shown inFIGS. 4a and 5a , during the inspiration phase, the obstruction element72/82 is positioned so that an aperture 71/81 is obstructed. As aresult, pressurized gas Gs coming from the gas source S is transmittedto the patient P.

As shown in FIGS. 4b and 5b , during the expiration phase, the aperture71/81 is at least partially open, which allows gas to circulate betweenan inside and an outside of the valve. As a result, when the patientexhales, the open aperture allows expired gas to exit the valve throughthe aperture 71/81. By controlling a size of the opening, one cancontrol the positive exhalation pressure in a PEEP mode. In someinstances, it is important to carefully control the PEEP in the gastransmission so that the patient can expire correctly. Controlling thePEEP is a way to balance the residual overpressure in the patient'slungs. To exert control of the PEEP, the position of the obstructionelement 72/82 is controlled in real time based on a sensed pressure inthe gas transmission duct.

If the gas source S becomes inoperative, the patient must still beallowed to breathe. In this circumstance, the controller of thebreathing assistance device will cause the obstruction element to assumea position which leaves the aperture 71/81 at least partially openduring both inspiration and exhalation. During the inspiration phase,because the aperture is open, the patient will be able to inhale airfrom the surrounding atmosphere via the aperture. During the expirationphase, the controller may still carefully control the position of theobstruction element, to thereby maintain the correct PEEP.

When the controller itself is disabled, the obstruction element cannotbe controlled. Therefore, a return mechanism is provided to ensure thatthe aperture remains open whenever the controller is not functional.This allows the patient to inhale from and exhale to the atmospherethrough the aperture. However, because the position of the obstructionelement cannot be controlled, it is not possible to control the PEEP.

In the embodiment illustrated in FIGS. 4a-c , a magnet 73 and coil 74are used to control the position of the obstruction element 72. Theseelements are designed so that when no signals are supplied to the coil74 from a controller, the magnetic attraction between the coil and themagnet ensure that the obstruction element 72 assumes the open position,as shown in FIG. 4c . Of course, in alternate embodiments, a returndevice, such as a biasing spring element, could also be used to ensurethat the obstruction element 72 returns to a position that leaves theaperture 71 open.

In the embodiment illustrated in FIGS. 5a and 5b , a magnet and coilalso control a position of the obstruction element. However, a returnspring is also provided to bias the obstruction element 82 to the openposition. Thus, when no signals from the controller are sent to thecoil, the obstruction element 82 assumes the open position, as shown inFIG. 5 b.

Linear Actuator

FIGS. 6a and 6b illustrate a linear actuator which could be used in agas regulating valve as described below. The linear actuator 1200includes a housing 1202 which houses a movable coil assembly and amagnetic element. A cable assembly 1204 provides electrical connectionsto the coil of the linear actuator 1200. The linear actuator has acentral aperture adapted to form a passage for receiving a gas flowpath. The moveable coil assembly and magnetic element are providedaround the periphery of the actuator, preferably around an annularperiphery of the actuator. The linear actuator has a preferably circularshape, although other shapes may be used. The actuator moves in a linearmanner.

FIG. 7 illustrates the coil and magnetic elements of the linearactuator. As shown in FIG. 7, a coil assembly 1210 includes a wire coil1211 which is wound about a bobbin 1213. The bobbin 1213 includes firstand second arms 1212 a, 1212 b which extend upward from one side of thebobbin 1213. Free ends 1217 a, 1217 b of the wire coil 1211 extend upthe first and second arms. Thus the arms 1212 a, 1212 b are wirealigning structures and the person skilled in the art would understandthat other forms of such structures may be utilized. In addition, thebobbin includes a plurality of depending legs 1215 which extend downwardfrom a second side of the bobbin which is opposite the first and secondarms. These legs 1215 are projections that facilitate the movement of anobstruction member, such as a membrane, in coordination with themovement of the coil as described in more detail below. It isacknowledged that other forms of projections on the second side of thebobbin may be utilized having different shapes and sizes that facilitatethe coordinated movement of the obstruction element with the movement ofthe coil.

In an example embodiment, the bobbin 1213 is formed of a moldedsynthetic material, and the wire coil 1211 is formed of coated copperwire. Of course, in alternate embodiments, other materials could beused.

The linear actuator also includes a magnet 1230, and a pole piece 1232.The magnet 1230 and pole piece 1232 preferably have a generallycylindrical shape as shown, but may have other shapes depending upon theshape of the other components of the linear actuator. The bobbin 1213and wire coil 1211, the magnet 1230 and the pole piece 1232 all fitinside a yoke 1220. This assembly also includes a flexible circuitassembly 1224.

In an example embodiment, the magnet is a sintered NdFeB magnet which iscoated with a corrosion resistant material, such as an epoxy, nickel orgold. The yoke 1220 and the pole piece 1232 are made of stainless steel.In alternate embodiments, other materials could be used for thesepieces.

FIG. 8 illustrates the coil assembly 1210 in greater detail. As showntherein, the wire coil 1211 is wound around the bobbin 1213. Protrusions1214 a, 1214 b are formed on the ends of the first and second arms 1212a, 1212 b. In some embodiments, the protrusions 1214 a and 1214 b areelliptical in cross-section.

The process of assembling the linear actuator is illustrated in FIGS. 9a-9 e. As shown in FIGS. 9a and 9b , the coil assembly 1210 is firstinserted into the yoke 1220. There are first and second apertures 1221a, 1221 b in the yoke 1220 which allow the first and second arms 1212 a,1212 b of the coil assembly to protrude through the apertures. Asexplained above, free ends 1217 a, 1217 b of the coil wire 1211 wouldalso extend up the first and second arms 1212 a, 1212 b and thus throughthe apertures 1221 a, 1221 b.

The flexible circuit assembly 1224 is then attached to the first andsecond arms of the coil assembly. The protrusions 1214 a, 1214 b on thetop of the first and second arms 1212 a, 1212 b are inserted intocorresponding apertures in the ends 1226 a, 1226 b of the flexiblecircuit 1224. The protrusions 1214 a, 1214 b on the tops of the firstand second arms 1212 a, 1212 b could be provided or otherwise attachedto the apertures in the ends of the flexible circuit 1224 via heatstaking (by melting the protrusions after they have been inserted intothe apertures in the flexible circuit), by an interference fit, via anadhesive, or by other suitable means.

In addition, the free ends of the wire coil 1217 a, 1217 b would beinserted into notches formed in the ends 1226 a, 1226 b of the flexibleassembly 1224. The ends 1217 a, 1217 b of the wire coil 1211 can beattached to the notches in the ends 1226 a, 1226 b of the flexiblecircuit 1224 by soldering, with an adhesive, or other suitable means.Any remaining free ends of the wires would then be trimmed off.

The portion of the flexible circuit 1224 underneath the electricalcontacts 1225 could be attached to the top of the yoke 1220 via anadhesive or any other type of fixation method. In some embodiments, anadditional mounting element may be positioned between the top surface ofthe yoke 1220 and the bottom surface of the flexible circuit assembly1224 during the assembly process. In a presently preferred embodiment, aspacer element is pre-attached to the underside of the flexible circuitassembly during its manufacture to thereby simplify the final assemblyof the linear actuator. The electrical contact assembly 1225 of theflexible circuit would include first and second electrical contactswhich are electrically coupled to the free ends of the wire coil viaconductive paths in the flexible circuit 1224.

As shown in FIGS. 9c -9 e, the magnet 1230 would then be mounted insidethe coil assembly 1210. Next, a pole piece 1232 would be mounted insidethe coil assembly 1210 and adjacent to the magnet 1230. The magnet andthe pole piece could be bonded together with an adhesive to form themagnetic element. In addition, the magnet could be bonded to the yoke1220 via an adhesive. In a presently preferred embodiment, once themagnet 1230 and pole piece 1232 have been mounted inside the coilassembly and the yoke, a wicking adhesive such as cyanoacryolate is usedto bond the yoke 1220 to the magnet 1230 and the pole piece 1232.

As shown in FIG. 10, the cable assembly 1204 would then be inserted intoa protrusion 1201 of the housing 1202. As shown in FIG. 10, first andsecond electrical contacts 1203 a, 1203 b on the cable assembly 1204,face upward within the housing 1202 after the cable assembly 1204 hasbeen mounted inside the protrusion 1201 on the housing 1202. The twoelectrical contacts 1203 a, 1203 b would be connected to two electricalwires running through the cable assembly 1204.

The assembly shown in FIG. 9e , which includes the coil assembly mountedin the yoke and the magnet and pole piece mounted inside the coilassembly, would then be mounted inside the linear actuator housing 1202,as shown in FIG. 11. The electrical contacts 1225 on the flexiblecircuit 1224 would be aligned with the electrical contacts 1203 a, 1203b on the cable assembly 1204. As a result, as the yoke 1220 is insertedinto the housing 1202, the electrical contacts 1225 of the flexiblecircuit 1224 would engage the electrical contacts 1203 a, 1203 b of thecable assembly 1204. Tabs 1205 on the housing 1204 would retain theyoke, coil and magnet assembly within the housing 1202. Other means forretaining the yoke, coil and magnet assembly within the housing 1202 maybe used such as latches, hooks, clamps etc. The end result is the linearactuator 1200 shown in FIGS. 6a and 6b . The structured design of thelinear actuator provides easy integration and assembly of the linearactuator resulting in reduced manufacturing costs.

In the assembled linear actuator, the yoke 1220 will be fixed to thehousing 1202, and the magnet 1230 and the pole piece 1232 would be fixedto the yoke 1220. Thus, these elements are intended to remainstationary. The coil assembly, which includes the wire coil 1211 woundaround the bobbin 1210 would be free to move axially within the device.The depending legs 1215 of the bobbin could bear against or be attachedto a movable portion of a gas regulating valve, such as an obstructionmember, to control a flow of a gas through the gas regulating valve. Thecoil has a low mass and very low drag resulting in the linear actuatorhaving a fast dynamic response. Having a fast dynamic response allowsthe linear actuator to be used in delivering a range of differentventilation modes as described in more detail below.

In an alternative embodiment the magnetic element may be movable and thecoil assembly may be fixed to the yoke (i.e. remain stationary). Thismay provide advantages in terms of power supply wiring. However, themagnetic element has a larger weight than the coil assembly which wouldconsequently result in a higher inertia and slower response time, thusreducing the overall efficiency of the actuator. Also a higher currentdemand would be required to drive movement of the magnet.

When the coil assembly of the linear actuator moves in the axialdirection, the first and second arms 1212 a, 1212 b of the bobbin wouldmove in the apertures 1221 a, 1221 b formed on the top surface of theyoke 1220. This will cause the ends of the arms 1226 a, 1226 b of theflexible circuit assembly 1224 to move with the arms 1212 a, 1212 b ofthe bobbin. The central portion of the flexible circuit assembly 1224 isfixed to the top surface of the yoke 1220. Thus, as the coil assemblymoves in the axial direction, it will cause the flexible circuitassembly to flex.

The linear actuator is highly efficient resulting in a low powerconsumption while being capable of delivering the optimum force requireddue to the magnetic design of the actuator. Furthermore, the linearactuator has a low overall weight and size due to the highly compactdesign of the linear actuator. The weight of the linear actuator may beapproximately 25 g to 30 g, preferably 27.5 g. The linear actuator yokemay have an external diameter of approximately 25 mm to 40 mm,preferably 30 mm and a height of the linear actuator in the fullyretracted position is approximately 16 mm to 20 mm, preferably 18.7 mm.Although it is acknowledged that other sizes, shapes and weights for thelinear actuator may be used whilst still being within the scope of theinvention.

When the linear actuator is installed in a gas regulating valve asdescribed above, there must be some mechanism to ensure that if power islost, the gas regulating valve will remain in an “open”position/configuration so that a patient can still breathe. In someembodiments, a spring or other biasing element in the gas regulatingvalve will act to bias the obstructing element of the gas regulatingvalve to the open position. In some embodiments, if there is noelectricity, the elasticity of the membrane itself can provide for areturn spring force to open the valve, thus allowing the patient tobreathe. The membrane acts as both the obstructing element and as areturn spring, eliminating the need for a separate return spring.

Gas Regulating Valve with Linear Actuator

An embodiment of a gas regulating valve which makes use of a linearactuator as described will now be explained. This gas regulating valvecould be used in a breathing assistance device as illustrated in FIG. 3.The design of the gas regulating valve ensures that no portions of thelinear actuator are in the air path used by a patient, or are otherwiseexposed to the air passing through the patient airway. As a result, itwould be possible to re-use the linear actuator for multiple patientswithout sterilizing the linear actuator between uses.

FIG. 12 illustrates the major elements of the gas regulating valve 1300.As shown therein, the gas regulating valve 1300 includes a distalhousing 1310, a membrane assembly 1320, a linear actuator 1330, aproximal housing 1340 and tubes 1350 that can be used to detect the flowrate and pressure within the gas regulating valve 1300.

In the embodiment illustrated in FIG. 12, the tubes 1350 would pass fromthe proximal location adjacent a patient to a distal location on gassupply assembly. Sensors for sensing the pressure and flow conditionsmay be located at the distal location on the gas supply assembly. Inalternate embodiments, gas pressure and flow sensors could be mounted onthe gas regulating valve itself. A processor or controller coupled tothe sensors could be located on the gas regulating valve itself at theproximal location, or at a distal location, such as on the gas supplyassembly.

To assemble the gas regulating valve 1300, the protruding portion 1342of the proximal housing 1340 would be inserted through a first end ofthe linear actuator 1330. The membrane assembly 1320 would be insertedinto a second end of the linear actuator 1330 and connected to theprotruding portion 1342 of the proximal housing 1340. The proximalhousing 1340 is locked on the membrane assembly 1320, as explained ingreater detail below. The distal housing 1310 is fitted over theexterior of the linear actuator module 1330. The sensing tubes 1350 areattached to corresponding apertures on the proximal housing 1340.

An assembled version of the gas regulating valve assembly 1300 isillustrated in FIG. 14. As shown therein, a protruding portion 1342 ofthe proximal housing 1340 extends down through the interior centralaperture of the yoke 1220, magnet 1230 and pole piece 1232 of the linearactuator 1330. A portion of the membrane assembly 1320 extends into theinner cylindrical aperture within the proximal housing 1340.

The membrane assembly 1320 is also shown in FIG. 13. As shown therein,the membrane assembly includes a clamp ring and flow restrictor 1329, anactuating ring 1326, and a membrane 1322. In an example embodiment, themembrane 1322 would include a plurality of smaller diameter and largerdiameter portions which form an s-shaped or serpentine cross-section.The inner diameter 1328 of the actuating ring 1326 would be insertedinto one of the smaller diameter portions of the membrane, asillustrated in FIG. 14. As mentioned above, the membrane acts as both anobstructing element and a return spring, eliminating the need for aseparate return spring.

As also illustrated in FIG. 14, the distal housing 1310 would be fittedover an exterior surface of the linear actuator module 1330 and attachedto the exterior surface of the proximal housing 1340. A lockingmechanism would be provided to lock the distal housing 1310 onto thehousing of the proximal housing 1340. In the embodiment illustrated theproximal housing 1340 comprises a latch mechanism 1348 and the distalhousing comprises a complementary latch receiving mechanism 1318 thatare connected to provide a regulating valve in one unit. Alternativelythe distal housing 1310 may comprise the locking mechanism 1348 and theproximal housing 1340 may comprise the latch receiving mechanism 1318.Furthermore it is to be understood that alternatively other known lockmechanisms, such as clips, hooks, etc may be used to connect theproximal housing 1340 to the distal housing 1310. In addition, anexterior ring 1324 of the membrane 1322 would be trapped between a step1314 on the distal housing 1310 and an exterior axial surface 1332 ofthe linear actuator assembly 1330. As a result, the membrane 1322 wouldform a seal between the interior of the proximal housing 1340 and theinterior of the distal housing 1310. This isolates the linear actuatorfrom the interior passage of the gas regulating valve, and thus the gaspassing through the valve. Thus, the membrane has multiple functions,and acts as both an obstructing element and a return spring as describedabove and to isolate the linear actuator from the gas flow to preventcontamination of the linear actuator by the patient gas flow.

The actuating ring 1326 includes an interior diameter 1328 which isinserted into a reduced diameter portion 1327 of the membrane 1322. Inaddition, the peripheral edge of the actuating ring 1326 includes acurved portion 1331 which curves upward towards the proximal housing1340.

The depending legs 1215 of the coil assembly 1210 of the linear actuatormodule 1330 bear against the flat annular surface of the actuating ring1326. The curved portion 1331 of the actuating ring 1326 surrounds thedepending legs 1215 of the coil assembly. When the coil 1211 isenergized, the resulting magnetic field interacts with the magnet 1230to cause the coil assembly to move downwards towards the distal housing1310. The legs 1215 of the coil assembly will push against the actuatingring 1326, which causes the membrane to move downwards against a sealingface 1312 of the distal housing 1310. By controlling the signal appliedto the coil 1211 of the coil assembly, one can selectively vary the gapbetween the sealing face 1312 of the distal housing and thecorresponding sealing face 1325 on the membrane 1322.

As also shown in FIG. 14, a connector 1352 of the tube assembly 1350would be inserted into a corresponding aperture 1344 of the proximalhousing 1340. One or more apertures 1346 in the proximal housing 1340would connect the interior of the tubes of the tube assembly 1350 to theinterior of the proximal housing. This would allow the flow rate andpressure within the proximal housing to be detected. As mentioned above,in alternate embodiments, the sensor elements to detect a flow rate orpressure could also be installed at this location within the gasregulating valve.

FIGS. 15a and 15b show the valve in the opened and closed positions,respectively. In FIG. 15a , the coil has been actuated so that the legs1215 of the bobbin pull the actuating ring 1328 upward towards theproximal end. This is preferably also the position of the coil in theun-actuated or non-powered state. Thus causes the membrane 1325 to moveaway from the sealing face 1312 of the distal housing 1310, opening theaperture. Thus, when the valve is in the open condition, as illustratedin FIG. 15a , the patient would be able to exhale.

In FIG. 15b , the coil has been actuated so that the legs 1215 of thebobbin push the actuating ring 1328 and the membrane 1325 against thesealing face 1312 of the distal housing 1310, to thereby close theapertures. Thus seals the valve so that gas supplied from the distal endcan be communicated to the patient under pressure.

If it is desirable to operate the valve to provide PEEP, then the coilwould be actuated to partially open the apertures while the patient isexhaling. In this instance, the actuating ring 1328 and the membrane1325 would be at a position between those shown in FIGS. 15a and 15b .The degree of movement of the coil could be carefully controlled in realtime based on feedback from sensed pressure and flow.

Advantageously the gas regulating valve has a small size and weightmaking it easier and more portable to use. In one embodiment the gasregulating valve, excluding the power supply cable and connector, has aweight of approximately 40 g to 60 g, preferably 45 g to 50 g, mostpreferably 47 g. The maximum external diameter is approximately 40mm to100 mm, preferably 45 mm to 60 mm, more preferably 45 mm to 50 mm, suchas 48.5 mm. The length of the gas regulating valve is approximately 60mm to 100 mm in length, more preferably 70 mm to 85 mm, more preferably70 mm to 80 mm, such as 77.7 mm. However, it is acknowledged that thegas regulating valve may be made in different weights, lengths anddiameters as well as different shapes whilst still being within thescope of the invention.

The linear actuator advantageously concentrically manages theinspiration flow, expiration flow and actuation of the membrane, byproviding movement along a single axis.

The flow restrictor 1329, as shown in FIG. 13, creates a pressuredifference across the flow path. The flow restrictor 1329 could have avariety of different designs, each of which is intended to providecertain characteristics. Thus, different flow restrictors could be usedin different embodiments of the valve. By selecting and installing theappropriate flow restrictor, one can customize the sensitivity of flowmeasurement, for example to customize the valve for different clientgroups such as adults and pediatrics.

In the same manner, the membrane may be tailored to have certaincharacteristics. For instance, some membranes might be relativelyflexible, which others are relatively stiff. Also, the membrane couldact as one of the elements which biases the gas regulating valve intothe open position when no electricity is applied to the device.

In some instances, medical personnel could select a certain membrane, acertain actuating ring and a certain flow restrictor, and then combinethem as part of the valve assembly so that the valve assembly willexhibit certain desired characteristics. In other instances, multipledifferent kits having these elements could be sold. Each kit wouldinclude a particular type of flow restrictor, actuating ring andmembrane, and each kit would be applicable to a certainapplication/patient.

The membrane assembly illustrated in FIG. 13, which includes the flowregulator 1329, the actuating ring 1328 and the membrane 1322 aredesigned to be removed, cleaned/sterilized, and reused multiple times.Of course, the membrane and actuating ring would be relatively low costelements which would be replaced on a periodic basis.

Operation of the valve will cause the coil to emit heat. And this heatcould be beneficial. For instance, the heat of the coil could help toprevent condensation on the valve.

As explained above, a gas regulating valve as illustrated ensures thatthe linear actuator module is outside of the patient air path, so thelinear actuator module can be reused with minimal surface cleaning.Other elements of the gas valve can either be sterilized or replaced asrequired. In addition, the distal housing and proximal housing, alongwith any pressure and flow sensing tubes, could either be sterilized orreplaced as needed.

Percussive Ventilation Mode

The linear actuator described above is capable of moving rapidly inresponse to electrical signals. Typically, the linear actuator couldmove the valve between the open and closed positions as rapidly as 30times per second or faster. When the gas regulating valve is opened andclosed quickly and repeatedly, the gas regulating valve can be used in apercussive ventilation mode, which can help to mobilize secretions in apatient's airway. In addition, the rapid response of the linear actuatorallows the gas regulating valve to quickly adapt to the existingoperating conditions as sensed by the pressure and flow sensors. Thiscan make it easier for a patient to breathe when connected to abreathing assistance device which includes this gas regulating valve.

Active Variable Vent

A linear actuator as described above could also be used as part of abreathing assistance device that includes a variable vented respiratorymask. An example of such a device is illustrated in FIG. 16.

The variable vented respiratory mask 1400 includes a mask shell 1402, agas supply hose 1406, and an optional gasket 1404 to ensure a good sealagainst a user's face. The mask 1400 also includes a flow regulator1410, which includes a linear actuator as described above. In thisinstance, however, the parts of the linear actuator could be physicallysmaller than in the linear actuators described above, which are providedon a gas supply line. An electrical cable 1412 would connect the flowregulator 1410 to a control mechanism.

As with the mechanisms described above, a linear actuator of the flowregulator 1410 would move a blocking element into and out of engagementwith an aperture in a flow passage to vary a size of the aperture thatallows gas to exit the mask. Thus, the linear actuator could selectivelyvary the flow rate out of the mask. If a gas is supplied to the mask ata relatively constant pressure, the linear actuator could control thesize of the aperture to ensure that a relatively constant pressure ismaintained within the mask while the user inhales and exhales. Thus,this type of a mask could be particularly useful in a CPAP system. Insome embodiments, the linear actuator could be actuated by a controllerthat monitors the internal pressure within the mask.

As with the valves described above, the elements of the linear actuatorin the flow regulator 1410 could be completely isolated from the gasflow path. As a result, it would be possible to re-use the linearactuator with different patients without the need to sterilize thelinear actuator itself. For instance, the linear actuator could beinstalled in a first flow regulator 1410 of a first user's mask, andthen the linear actuator could be removed from that mask and installedinto a flow regulator 1410 of a second user's mask without sterilizingthe linear actuator.

A mask as illustrated in FIG. 16 might also be used in a system whichincludes a flow valve 1420 having a linear actuator as described abovein the gas supply line 1406. The linear actuator in the flow valve 1420would also be connected to a controller by an electrical cable 1422. Inthis type of a system, the linear actuator of the valve 1420 in the gassupply line and the linear actuator of the flow regulator 1410 of themask could be actuated by the same controller. And by selectivelyactuating the two linear actuators, the controller could achieveextremely good control over the flow of gas into and out of the mask.

Retrofit to Existing Devices

The gas regulating valve described above is able to control the deliveryof a gas to a patient with a relatively compact and simple structure. Assuch, the valve could be retrofitted onto existing ventilator andbreathing assistance devices such as those illustrated in FIGS. 1a-1dand 2a -2 d. In particular, it may be possible to retrofit one of thegas regulating valves described above into the embodiment as shown inFIGS. 2a -2 d, to replace the proximal valve which was previouslyoperated based on air pressure. This would eliminate the need for aseparate air tube 23 to control the opening and closing of the gasregulating valve, and it would likely simplify the control structure.These changes to the device shown in FIGS. 2a-2d would reduce the sizeof the device, and possibly make the device more easily portable.Moreover, a gas regulating valve with an electrically controlled linearactuator may be capable of opening and closing more quickly andprecisely.

Breathing Assistance Systems With Relocated and/or Multiple ValveAssemblies

The breathing assistance system illustrated in FIG. 3 includes a singlegas regulating valve 32 that controls the flow of air delivered to thepatient, and the gas regulating valve is located adjacent to the patientP.

In some embodiments, the gas source S of the breathing assistance systemshown in FIG. 3 delivers humidified gas or humidified atmospheric air toprovide therapy to a patient. The humidified gas is typically outputfrom the gas source S at a temperature above normal ambienttemperatures. The humidified gas travels through the gas delivery linesand the gas regulating valve before reaching the patient. As it travelsalong this flow path, the humidified gas will tend to cool down andcondense. As a result, some of the water vapor in the humidified gas maycondense and collect within the gas supply lines. The presence ofcondensed water can interfere with providing therapy, and can lead topatient infection due to microbial growth.

In some breathing assistance devices that deliver humidified gas,therapy is delivered only intermittently. For instance, the breathingassistance device may be designed to deliver therapy only when required,and to turn off when therapy is not required. Therapy may only beprovided when snoring is detected, and when snoring stops, the therapymay be discontinued. In other instances, the breathing assistance devicemay be configured to provide therapy only when the patient is in sleepstage 4, or only when the patient is in sleep stages 3 or 4. At allother times, no therapy would be provided.

In other instances, a breathing assistance device may be configured toprovide therapy on a periodic basis. For instance, the breathingassistance device may be configured to deliver therapy for a firstpredetermined period of time, and to then discontinue therapy for asecond predetermined period of time. This on/off cycle can continueindefinitely.

When a breathing assistance device that delivers humidified gas isswitched on and off, during the off times, any humidified gas thatremains in the gas supply lines will tend to cool, and the water vaporin the gas may condense and collect in the gas supply pipes. As noted,the presence of condensed water in the gas supply lines can reduce theeffectiveness of subsequent treatment cycles, and it poses a risk ofinfection due to microbial growth.

With a system as illustrated in FIG. 3, when treatment has ended, or hasbeen temporarily discontinued, the gas regulating valve will revert toan “open” position, which allows a patient to breathe, and which alsoopens the end of the gas delivery line adjacent the patient to theatmosphere. However, because the only opening to the atmosphere is atthe patient side, it is difficult for all of the water vapor in thehumidified air in the gas delivery lines to escape.

FIG. 17 illustrates a first alternate embodiment in which the gasregulating valve has been re-located from the patient side to the gassource side. In this embodiment a gas source 2000 provides humidifiedgas or humidified atmospheric air through an output pipe 2012. A distalgas regulating valve 2100 is connected to the output pipe 2012. Thedistal gas regulating valve 2100 is also coupled to a first end of a gassupply line 2010 which leads to a patient interface 2030. The patientinterface 2030 may be any type of patient interface unit, such as anasal mask, full face mask, nasal prongs, or a nasal cannula such as theones used to provide open CPAP therapy. The distal gas regulating valve2100 can be one of the linear actuated gas regulating valves asillustrated in FIGS. 12-15 b.

A system as illustrated in FIG. 17 could be used as an OpenCPAP system,in which the gas regulating valve is attached to the outlet of ahumidifier. In some embodiments, a supplemental gas supply line 2040 mayalso deliver predetermined amounts of an additional gas, such as oxygen,into the gas supply line 2010. The supplemental gas supply line 2040could be coupled to the gas supply line 2010 on the patient side of thedistal gas regulating valve 2100, as illustrated in FIG. 17. Inalternate embodiments, the supplemental gas supply line 2040 could becoupled to the output pipe 2012.

So long as the distance between the gas source 2000 and the patientinterface 2030 is short, it is possible to re-locate the gas regulatingvalve to a position adjacent the gas source, and doing so helps toreduce the above-discussed problems with condensation. During treatmentcycles, the distal gas regulating valve 2100 would be closed, or atleast partially closed. Therefore the therapeutic airflow passes throughthe distal gas regulating valve 2100 and through the delivery tube 2010to the patient interface.

When treatment is discontinued, the distal gas regulating valve 2100would open the gas delivery tube 2010 to the atmosphere and no gas wouldflow to the patient interface. Thus, the air delivery tube 2010 isdecoupled from the gas source. The gas regulating valve may be used tocontrol the delivery of the treatment only at desired times or whenrequired, as described above.

In some embodiments, the gas source may also be turned off orinactivated at the same time that the distal gas regulating valve 2100is opened to the atmosphere to discontinue treatment. This would alsoresult in no flow through the humidifier/gas source, which would resultin less cooling of the heated water in the humidifier. Consequently,when therapy is to be re-started, the temperature of the water in thehumidifier is substantially maintained such that effective treatment maybe recommenced quickly. There is a reduction in or no delay due toreheating of the water in the humidifier. When treatment is to berestarted, the gas source is turned on or reactivated and the distal gasregulating valve 2100 is closed, or at least partially closed, to theatmosphere.

When treatment is discontinued, and the patient is breathing through thegas delivery tube 2010, the patient's respiration would flush out anymoisture remaining in the gas delivery tube from the treatment cyclethat just ended. Thus, placing the only gas regulating valve at the gassource 2000 side of the gas delivery tube 2010 helps to preventcondensation within the gas delivery tube. The gas regulating valve 2100provides a vapor suspension system that eliminates or at least reducesthe occurrence of condensation within the air delivery tube and isolateshot water in the humidifier. The saturated vapor present in the systemat the time treatment is interrupted is vented out rapidly with thepatient providing the “flushing” circuit. Creating a draft through theair delivery tube allows the tube to dry out and prevents condensation.

In one embodiment this system may be used with an Open CPAP device suchas the devices described in the Applicant's co-pending PCT applicationPCT/AU2009/000671, filed 28 May 2009, and published as WO 2009/146484.In Open CPAP systems, the patient interface may include a nasal cannula.In other embodiments, the system may be used with a CPAP system using amask or nasal prongs.

FIG. 18 illustrates another alternate embodiment where a gas regulatingvalve is located at both ends of the gas delivery tube 2010. In thisembodiment, a proximal gas regulating valve 2200 is connected between asecond end of the gas delivery tube and the patient interface.

The breathing assistance device illustrated in FIG. 18 is configuredsuch than when therapy is stopped, both the distal gas regulating valve2100 and the proximal gas regulating valve 2200 default to the openposition. This means that both ends of the gas supply line 2010 are opento the atmosphere, which helps to more rapidly dissipate and evaporateany moisture left in the gas supply line 2010 when therapy has beendiscontinued.

Some breathing assistance devices as illustrated in FIGS. 3, 17 and 18include heated gas delivery tubes that are designed to promote dryingand to reduce undesirable condensation. If only a proximal gasregulation valve were provided, as illustrated in FIG. 3, and if thepatient interface side is lower than the gas source, heating of the gasdelivery lines may not be effective in flushing out moist air betweentreatment cycles. Under those circumstances, heating the moist airwithin the gas delivery lines would cause the moist air to rise towardthe gas source side where it cannot escape the gas delivery lines.

However, when both a distal gas regulation valve 2100 and a proximal gasregulation valve 2200 are provided, it will not matter which end ishigher. Heating of the gas delivery lines between treatment cycles,while both gas regulating valves are open, will cause the moist gaswithin the gas delivery lines to rise toward and escape from whicheverend is higher.

In some embodiments of the breathing assistance devices illustrated inFIGS. 17 and 18, the distal gas regulating valve 2100 may also includemeans for sealing off the output pipe 2012 when treatment is beingdiscontinued. In these embodiments, when the distal gas regulating valve2100 is placed in the “open” position, the gas delivery line 2010 wouldbe open to the atmosphere and the output pipe 2012 would be sealed.Sealing the output pipe would help to prevent any heated gas within thegas source 2000 from escaping during a non-treatment period. Sealing theoutput pipe 2012 would also help to keep any heated water or liquidwithin the gas source 2000 at a high temperature. When treatment islater re-started, the gas source could immediately be deliveringhumidified gas, as there would be no delay while the gas source 2000heats the liquid up to a temperature required to provide the humidifiedgas.

In all of the embodiments described above, the gas regulating valves andthe gas source preferably would be linked such that if any of theelements fail, all elements would be turned off. As explained above,when the gas regulating valves are turned off, they simply default tothe open position.

Breathing Assistance Systems With Expiratory Flow Measurement

FIG. 19 illustrates a breathing assistance device. The device includes aflow controller 3000, which supplies a flow of gas to a patientinterface 3040 via a gas regulating valve 3030. The gas regulating valvecould be a linear actuated gas regulating valve as illustrated in FIGS.6a -15 b, and as described above.

The flow controller 3000 includes a flow generator 3010 that generates aflow of a treatment gas, which would typically be atmospheric air. Anon-return valve 3012 is operable to selectively block an output lineconnected to the flow generator 3010. Also, a supply line pressuresensor 3016 senses the pressure in a gas supply line 3017 leading to thegas regulating valve 3030. The flow generator 3010, the non-return valveand the supply line pressure sensor 3016 are all coupled to a controller3014.

The gas regulating valve opens and closes in response to a signalprovided from the controller 3014 via a valve driver line 3018.

Also, two bypass flow conduits 3022 are coupled between the gasregulating valve 3030 and a flow sensor 3020 in the flow controller.When a patient exhales, a small portion of the expiratory flow passesdown one bypass flow conduit, passes across the flow sensor 3020, andflows back down the other bypass flow conduit back to the gas regulatingvalve. A signal generated by the flow sensor 3020, which is indicativeof the expiratory flow, is communicated to the controller 3014.

The breathing assistance device is configured such that when a patientis inhaling, the non-return valve 3012 is open, and the gas regulatingvalve 3030 is closed. As a result, pressurized gas flows from the flowgenerator 3010 through the gas supply line 3017, through the gasregulating valve 3030, and into the patient interface 3040. When thepatient is exhaling, the controller causes the non-return valve 3012 toclose, and the gas regulating valve 3030 to at least partially open. Asa result, compressed gas does not flow down the gas supply line 3017,and the patient is allowed to exhale through the opened gas regulatingvalve 3030. In some instances, the degree to which the gas regulatingvalve is opened is selectively varied by the controller 3014 to maintaina desired pressure throughout the exhalation process.

In many instances, to provide proper treatment to the patient, it isdesirable to measure the patient's expiratory flow. In the embodimentillustrated in FIG. 19, the expiratory flow is measured by the flowsensor 3020. In alternate embodiments, the controller 3014 may determinethe expiratory flow based on a signal from the flow sensor 3020.

Providing the bypass flow conduits and the flow sensor 3020 addsconsiderable bulk and cost to the system. Also, arranging the bypassflow conduits can be inconvenient. The fact that a portion of thepatient's exhalation flows through the bypass flow conduits 3022 andthrough the flow sensor 3020 means that the exhalation resistance forthe patient may be larger than it otherwise would be. In addition,because the patient's exhalations are communicated to the flow sensor,the flow sensor 3020 becomes contaminated, and it is necessary toreplace the flow sensor 3020 for each new patient that uses the system.

Another approach to sensing the patient's expiratory flow can beaccomplished with a system as illustrated in FIG. 20. In thisembodiment, the flow sensor 3020 and the bypass flow conduit areeliminated. However, a pressure sensor 3042 is added to the patientinterface. The pressure sensor can be an electronic sensor that derivespower from the power line running to the gas regulating valve 3030, andwhich sends a sensor signal to the controller 3014 along one or moreadditional wires that are run with the valve driver line. In alternateembodiments, the pressure sensor could be located on the proximal sideof the gas regulating valve 3030.

As explained above, during expiration, the gas regulating valve 3030will be at least partially open, and the patient will exhale through theopening to the atmosphere. The expiratory flow can be calculated basedon the pressure drop that occurs between the patient interface and theatmosphere, and the impedance offered by the gas regulating valve 3030.If Pmask is the pressure on the patient side of the gas regulatingvalve, and Patm is the atmospheric pressure, The general formula wouldbe:

Expiratory Flow=(Pmask−Patm)/Valve Impedance

As explained above, the opening provided by the gas regulating valvewould be selectively varied by the controller 3014 to maintain a desiredpressure during exhalation. As a result, the valve impedance would varyduring the exhalation.

As explained above, a gas regulating valve as illustrated in FIGS.6a-15b is opened and closed by applying a signal to a coil. If no signalis applied to the coil, the valve remains open. The greater the value ofthe signal applied to the coil, the more the valve will close. As aresult, the amount of flow resistance provided by the gas regulatingvalve is proportional to the drive signal applied to the gas regulatingvalve. The greater the value of the signal, the more the valve closes,and the greater the flow resistance.

If the valve impedance was linearly proportional to the value of thesignal applied to the valve by the controller 2014, one could simply usethe value of the drive signal, along with a correction constant as asubstitute for the actual valve impedance. If the correction factor wasK, the equation used to calculate the expiratory flow could be expressedas:

Expiratory Flow=(K)*(Pmask−Patm)/Valve Drive Signal

In fact, the valve impedance is not linearly proportional to the valueof the drive signal. However, after conducting experimentation, it ispossible to create a lookup table that will provide the valve impedancefor various different values of the valve drive signal. And the valveimpedance obtained through the lookup table could then be used, alongwith the pressure differential, to calculate the expiratory flow.

Also, if the pressure sensor 3042 used in the patient interface 3040 oron the patient side of the gas regulating valve indicates the pressureon the patient side of the gas regulating valve relative to atmosphericpressure, the portion of the equation calling for the pressuredifferential between Pmask and Patm is given simply by the output of thepressure sensor 3042.

In view of all of the foregoing, it is possible to closely estimate theexpiratory flow using the value of the signal applied to the gasregulating valve, and the value of the signal output from the pressuresensor 3042.

In alternate embodiments, the pressure on the patient side of the gasregulating valve 3030 could also be sensed by having a single bypassconduit 3022 coupled to an aperture on the patient side of the gasregulating valve. This single bypass flow conduit could lead to apressure sensor on the flow controller 3000.

During exhalation, the non-return valve 3012 should be closed, and nopositive air pressure should be applied to the distal side of the gasregulating valve. However, if a particular embodiment of a breathingassistance device called for positive air pressure to be applied by theflow generator 3010 during expiration, the value of that pressure wouldbe provided by the supply line pressure sensor 3016. Thus, the value ofthat pressure could be taken into account in calculating the expiratoryflow.

Similar techniques could be used to estimate patient inspiratory flow.During patient inspiration, the gas regulating valve 3030 will beclosed, and gas will be flowing from the flow supply 3010, through thegas supply line 3017, through the gas regulating valve 3030 and into thepatient interface 3040. If Pfg is the pressure of the gas as supplied bythe flow supply, Pmask is the pressure on the patient side of the gasregulating valve, and Total Impedance is the impedance provided by thegas supply line 3017 and the gas regulating valve 3030, then theinspiratory flow is given the the equation:

Inspiratory Flow=(Pfg−Pmask)/Total Impedance

Because a pressure sensor 3016 is provided at the flow supply 3010, Pfgwould be known. Likewise, the pressure on the patient side of the gasregulating valve 3030 would be sensed by a pressure sensor on thepatient interface or the patient side of the gas regulating valve, soPmask would also be known. As also noted above, the pressure on thepatient side of the gas regulating valve might also be sensed by apressure sensor on the flow controller 3000 that is coupled to thepatient side of the gas regulating valve 3030 by a bypass conduit.

The total impedance of the system would include the impedance providedby the gas regulating valve 3030 and the elements located between theflow supply 3010 and the gas regulating valve, most notably, the gassupply line 3017. The impedance would vary in a non-linear fashion withrespect to the supply pressure. Thus, experimentation could be conductedto create a look up table that indicates the total impedance as afunction of the gas supply pressure Pfg. Alternatively, the look uptable could indicate the total impedance as a function of the pressureon the patient side of the gas regulating valve.

Once Pfg, Pmask and Total Impedance are determined, as described above,it is possible to estimate the inspiratory flow.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.

Furthermore, each individual component of any given assembly, one ormore portions of an individual component of any given assembly, andvarious combinations of components from one or more embodiments mayinclude one or more ornamental design features.

In addition, while the invention has particular application to patientswho require a ventilator, or who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, bariatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

What is claimed is:
 1. A linear actuator for a gas regulating valve,comprising: a housing; a yoke mounted inside the housing; a coilassembly inserted within the yoke; a magnetic element inserted withinthe coil assembly; a circuit assembly coupled to the outer surface ofthe yoke; and a central aperture adapted to received a gas flow paththerethrough; wherein the coil assembly includes a bobbin having a wirecoil wound thereon and wire aligning structures adapted to facilitateattachment of ends of the wire coil to the circuit assembly throughapertures provided in the yoke; and wherein the coil assembly is adaptedto move in a linear direction within the yoke in response toelectro-magnetic forces applied by the magnetic element.
 2. The linearactuator of claim 1, wherein the circuit is a flexible circuit.
 3. Thelinear actuator of claim 1 or 2, wherein the magnetic element comprisesa magnet with a pole piece coupled to the magnet.
 4. The linear actuatoraccording to anyone of claims 1-3 having a circular cross-sectionalshape.
 5. The linear actuator according to claim 4 wherein the centralaperture has a circular cross-sectional shape.
 6. The linear actuatoraccording to anyone of claims 1-5, wherein the wire aligning structuresare a pair of arms that extend from a first end of the bobbin.
 7. A gasregulating valve, comprising: the linear actuator according to anyone ofclaims 1-6; a housing including a gas flow passage that is configured tobe located within the central aperture of the linear actuator; and amembrane assembly; wherein the linear actuator is isolated from gasflowing through the gas flow passage.
 8. The gas regulating valveaccording to claim 7 wherein the housing is formed of two portions, aproximal housing portion and a distal housing portion, the two portionsbeing coupled together to secure the linear actuator within the housing.9. The gas regulating valve according to claim 8 wherein the proximalhousing portion includes a protrusion that forms the gas flow passage,and wherein the gas flow passage is inserted through a first end of thecentral aperture of the linear actuator.
 10. The gas regulating valveaccording to claim 9 wherein the membrane assembly is inserted into thesecond end of the linear actuator and coupled to the gas flow passage ofthe proximal housing portion.
 11. The gas regulating valve according toclaim 10 wherein the distal housing portion is inserted over themembrane assembly and linear actuator and couples to the proximalhousing portion.
 12. The gas regulating valve according to anyone ofclaims 7-11, further comprising a sensing tube attached to the housing.13. The gas regulating valve according to claim 8 wherein one of theproximal housing portion and the distal housing portion includes atleast one aperture adapted to allow gas passing through the valve toescape to atmosphere.
 14. The gas regulating valve according to claim 13wherein the membrane assembly comprises an obstruction element, anactuator ring and a clamping ring, and the obstruction element ismovable between a closed position where it closes off the at least oneaperture and an open position where it opens the at least one aperture.15. The gas regulating valve according to claim 14 wherein theobstruction element is coupled to the linear actuator such that thelinear actuator causes movement of the obstruction element between theopen and closed positions.
 16. The gas regulating valve according toanyone of claim 14 or 15 wherein the obstruction element is a membrane.17. The gas regulating valve according to claim 16 wherein the membranefunctions to control the opening of the least one aperture and toisolate the linear actuator from the gas flow path.
 18. The gasregulating valve according to anyone of claim 16 or 17 wherein themembrane acts as a return spring to ensure the at least one aperture isopen to atmosphere in case of power failure of the gas regulating valve.19. A linear actuator for a gas regulating valve, comprising: a housing;a yoke mounted inside the housing; a bobbin that is movably mountedinside the yoke and that has first and second arms that extend from afirst end of the bobbin, wherein a wire coil is wrapped around thebobbin; a flexible circuit assembly having a central portion that isattached to the yoke and first and second extensions that extend fromthe central portion and that are attached to the first and second armsof the bobbin, respectively, wherein first and second electricalcontacts are formed on the central portion, the first and secondelectrical contacts being coupled, respectively, to first and secondends of the wire coil; and a magnet that is attached to the yoke. 20.The linear actuator of claim 19, wherein the first and second ends ofthe wire coil extend up the first and second arms, respectively, of thebobbin and are electrically coupled, respectively, to first and secondelectrically conductive paths in the flexible circuit assembly, thefirst and second electrically conductive paths being coupled,respectively, to the first and second electrical contacts of theflexible circuit assembly.